What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis involving immune modulation include biologics such as TNF-alpha inhibitors (e.g., etanercept), IL-17 inhibitors (e.g., secukinumab, ixekizumab), and IL-12/23 inhibitors (e.g., ustekinumab). Known side effects of these treatments can include increased risk of infections, injection site reactions, and potential exacerbation of inflammatory bowel disease. Long-term use may also be associated with an increased risk of certain cancers and cardiovascular events. Methotrexate, another immune-modulating agent, can cause liver toxicity, bone marrow suppression, and lung disease.

What prior FDA approvals exist?

Several immune-modulating therapies have been FDA-approved for the treatment of plaque psoriasis. These include TNF-alpha inhibitors such as etanercept, infliximab, and adalimumab, which reduce inflammation by blocking tumor necrosis factor-alpha. IL-17 inhibitors like secukinumab and ixekizumab target the interleukin-17 pathway, reducing inflammation and plaque formation. IL-12/23 inhibitors such as ustekinumab block interleukins 12 and 23, which are involved in the inflammatory process of psoriasis. These biologics have shown efficacy in managing moderate-to-severe plaque psoriasis by modulating the immune response.

What other types of research exist?

Promising novel alternatives to JNJ-77242113 for plaque psoriasis include: 1) Vunakizumab, an interleukin 17A monoclonal antibody, which has shown efficacy and tolerability in phase II trials. 2) Secukinumab, which has demonstrated significant improvement in skin and joint symptoms and is well-tolerated in patients with comorbid conditions. 3) Risankizumab, an anti-IL-23p19 biologic, which has shown superior efficacy compared to ustekinumab in phase III trials.

← Back to Search

Monoclonal Antibodies

JNJ-77242113 for Plaque Psoriasis (ICONIC-TOTAL Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for phototherapy or systemic treatment for plaque psoriasis

Failed to respond to at least 1 topical therapy (example, corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) used for treatment of psoriasis

Must not have

Current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)

A current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 165 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called JNJ-77242113 to see if it can help people with plaque psoriasis in hard-to-treat areas like the scalp, genital area, and palms/soles. The medication works by calming the immune system and slowing down skin cell growth. The goal is to find a more effective treatment for these challenging cases.

Who is the study for?

This trial is for people who've had plaque psoriasis, including on the scalp, genitals, or palms and soles of the feet, for at least half a year. They should need systemic treatment or phototherapy and have tried at least one topical therapy without success. Participants must not have non-plaque psoriasis types or skin conditions that could interfere with the study.

What is being tested?

The trial tests JNJ-77242113's effectiveness against placebo in treating plaque psoriasis in sensitive areas. It aims to see if this new medication can improve symptoms better than a non-active treatment (placebo).

What are the potential side effects?

Possible side effects of JNJ-77242113 may include reactions related to allergies or hypersensitivity since participants with known intolerance to its components are excluded from the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for light therapy or medication for my plaque psoriasis.

Select...

I have tried at least one skin cream for psoriasis without success.

Select...

I have plaque psoriasis on parts of my body other than my scalp, genitals, or palms/soles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My psoriasis started or got worse after taking certain medications.

Select...

I do not have severe or worsening problems with my kidneys, liver, heart, blood vessels, lungs, stomach, hormones, nerves, blood, joints, mind, or metabolism.

Select...

My psoriasis is not the plaque type but another form like guttate or pustular.

Select...

I have skin conditions other than plaque psoriasis, or severe palmoplantar pustulosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 165 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 165 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 165 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 and Greater Than or Equal to (>=) 2 Grade Improvement From Baseline at Week 16

Secondary study objectives

Change From Baseline in BSA at Week 16

Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-25 (PROMIS-25) Score at Week 16

Change From Baseline in Domain Scores of the Patient-reported Outcomes Measurement Information System-29 (PROMIS-29) Score at Week 16

+26 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: JNJ-77242113Experimental Treatment1 Intervention

Participants will receive JNJ-77242113 from Week 0 through Week 156.

Group II: PlaceboPlacebo Group2 Interventions

Participants will receive placebo from Week 0 through Week 16 and thereafter will receive JNJ-77242113 from Week 16 through Week 156.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

JNJ-77242113

2022

Completed Phase 2

~640

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Plaque Psoriasis treatments often target the immune system to reduce inflammation and slow down the overproduction of skin cells. TNF-alpha inhibitors, such as etanercept and adalimumab, block the tumor necrosis factor-alpha, a cytokine involved in systemic inflammation. IL-12/23 inhibitors, like ustekinumab, target interleukins 12 and 23, which are crucial in the inflammatory pathway of psoriasis. IL-17 inhibitors, such as secukinumab and ixekizumab, block the action of interleukin-17, another key cytokine in psoriasis pathogenesis. These treatments are significant for patients as they help manage symptoms, reduce flare-ups, and improve quality of life by addressing the underlying immune dysregulation in Plaque Psoriasis.

Position Statement on Secukinumab in the Management of Plaque Psoriasis: The Malaysian Perspective.